| Methods |
Multicenter, randomized, double‐blind, placebo‐controlled trial |
| Participants |
Adult patients (> 18 years) with ulcerative colitis (N = 305) in remission (revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0 and mucosal appearance < 2)). Relapse was defined as SDAI rectal bleeding score > 1 and a mucosal appearance score > 2, a UC flare, or initiation of medication to treat a UC flare |
| Interventions |
Mesalamine granules (Apriso) 1.5 g/day dosed once daily (n = 209) or placebo (n = 96) for 6 months |
| Outcomes |
Primary: percentage of patients who were relapse free at 6 months. Secondary: percentages of patients with each level of change from baseline in rectal bleeding score, mucosal appearance score, physician's rating of disease activity and stool frequency on SDAI at months 1, 3, and 6 and end of treatment; percentage of patients classified as treatment success, relapse‐free duration, and adverse events |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, matching placebo |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Drop‐outs balanced across intervention groups with similar reasons for withdrawal |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
